The present invention relates to an apparatus and method of muscle and connective tissue therapy and pain relief that deploys dynamic electrical stimulation.
Electrical stimulation is known to reduce or block pain signals conduction in nerves. Transcutaneous electrical nerve stimulation (TENS) has been used to treat pain, and other medical conditions. TENS units are worn almost continuously by the patient, and the technical evolution of these devices is generally disclosed in the following US Patents, which are all incorporated herein by reference:
U.S. Pat. No. 8,014,877 B2 (J. Colthurst) published Sep. 6, 2011
U.S. Pat. No. 6,662,051 B1 (S. Eraker et al.) published Dec. 9, 2003
U.S. Pat. No. 4,503,863 (J. Katims) published May 12, 1985
U.S. Pat. No. 4,121,593 (E. Kastrubin et al.) published Oct. 24, 1978
U.S. Pat. No. 1,908,688 (L. Call) published May 16, 1933
U.S. Pat. No. 1,155,036 (S. Brooks et al.) published Sep. 28, 1915
More recently, it has been suggested that the efficacy of pain treatment with electrical stimulation can be improve by optimizing the local placement of electrode within muscles based muscle electrical activity, from a electromyagram (EMG), as disclosed in the U.S. patent application Ser. No., 2012/0065538 A1 (E. Friedman), which published Mar. 15, 2012, and is incorporated herein by reference. A clinician uses the disclosed device to optimize the placement of embedded needle electrodes from the received EMG signal. The spectrum of signal received at the needle electrodes is filtered to acquire signals only within a diagnostic band of frequencies corresponding to the EMG spectrum, which is generally considered to be from about 100-1500 Hz, and by some to be in more specific frequency bands of about 100-200 Hz. and/or 500-1500 Hz. The applied stimulation signals are described as having amplitude: 0-20 mA, and more preferably 1 mA, which are applied at a frequency: 1, 3, 5, 7 or 10 Hz, with a pulse width between about 50 to 500 microseconds.
While the application goes on to describe that the stimulation parameters can be varied widely, the application does not teach or disclose a means to improve on the major problem of TENS use, which is accommodation, in which stimulated nerves over time accommodate to the electrical impulse, and eventually diminish the effectiveness of blocking pain signal transmission to the brain. In such accommodation, pain relief is typically sacrificed due to the interaction between amplitude and pulse width. As the duration of a pulse is shortened, the amplitude must be increased to maintain the required pain signal blocking effect. Hence, such devices to be effective for long term pain management must be capable of modulating the amplitude and pulse width over long treatment duration. Further, the device could not realistically be used by the typical patients, as it involves insertion of electrode needles sub-dermal, as well as clinical expertise in interpreting the results to revise the stimulation schedule to account for such accommodation.
Hence, it would be a significant advance if improvements to electro-stimulation pain treatment did not require implantation of needle electrodes.
It would also be significant advance to have a method of treatment that did not require constant external stimulation, as well as the implanting of electrodes within muscle or other tissue.
It would also be significant advance to have a method of treatment that relieved pain relatively quickly, without the accommodation to the stimulation signal, and that such treatment lasted a considerable amount of time, at least days to weeks, to preclude accommodation from repeated use of the same stimulation signal.
It is a primary object of the present invention to provide an improved mean for therapeutic healing as well as pain reduction, without the deficiencies associates with TENS and other prior art treatment methods. Such deficiencies include without limitation, considerable clinical expertise in identifying the optimum treatment protocol for a particular condition, and either the external placement or insertion of electrodes below the skin.
It is a further object of the present invention to provide therapeutic benefits beyond mere pain relief.